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The Protocol Review and Monitoring SystemGuidelines and ProceduresClinical Trials Review CommitteeScientific and Accrual Monitoring CommitteeThe University of Chicago Comprehensive Cancer Center5841 South Maryland Avenue, MC 1140Chicago, Illinois 60637-1470

Table of Contents1.0 – Organizational Structure2.0 - Clinical Trials Review Committee (CTRC)2.1 - Introduction2.2 - Purpose2.3 - Scope2.4 - StructurePage 3Page 3Page 4Page 53.0 - Clinical Trials Review Committee Procedures3.1 - Overview3.2 - Prospective Study Submission3.3 - Retrospective Study Submission3.4 - Pre-Meeting PreparationPage 6Page 6Page 6Page 74.0 - Clinical Trials Review Committee Meetings4.1 - Meeting Policies4.2 - Meeting Outcomes4.3 - Subsidy Scoring4.4 - Amended Protocol ReviewPage 7Page 8Page 8Page 85.0 – Scientific and Accrual Monitoring Committee (SAM)5.1 - Introduction5.2 - Purpose5.3 - Scope5.4 - StructurePage 8Page 9Page 9Page 96.0 – Scientific and Accrual Monitoring Committee Procedures and Meetings6.1 - Pre-Review Process6.2 - Review Process6.3 - Review Outcome, Notification and Study Closure6.4 - Review of Amendments6.5 - Studies Exempt from Review6.6 - Meeting Policies6.7 - Subsidy ScoringPage 10Page 10Page 10Page 11Page 11Page 11Page 11Appendix 1: CTRC Submission and Response GuidelinesAppendix 2: Non-Therapeutic Protocol TemplateAppendix 3: SAM PI Response WorksheetPage 12Page 22Page 242 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

1.0 – Organizational StructureClinical Research AdvisoryCommittee (CRAC)Scientific Review &MonitoringCTRCClinical TrialsReview CommitteeSAMScientific &Accrual MonitoringCommitteeData & SafetyMonitoringWeeklyMonitoringConferencesAdverse ogramIRBHRPCHigh RiskProtocol Conference2.0 - Clinical Trials Review Committee2.1 - IntroductionThe Protocol Review Monitoring System (PRMS) at the University of Chicago Comprehensive Cancer Center(UCCCC) is comprised of two committees, one of which is the Clinical Trials Review Committee (CTRC). TheCommittee is appointed by, and is under the overall direction of the Associate Director for ClinicalSciences, who is also the Chair of the Clinical Research Advisory Committee (CRAC). The CTRC isresponsible for the initial scientific review of new cancer-related clinical trials.2.2 - PurposeThe CTRC is responsible for the evaluation of scientific merit and data and safety monitoring plans forall cancer-related clinical research performed at the UCCCC. The Committee meets once a month to:a)Review all new clinical trials for scientific merit. The review takes into account the scientificrationale, study design, type of support required to implement the research, adequacy of3 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

biostatistical input, anticipated accrual, study feasibility, and the estimated period forcompletion.b)Assess adequacy of data and safety monitoring plans (including audit procedures andfrequency) for each protocol.c)Determine the level of study risk (criteria described in the UCCCC DSM plan) andrecommend frequency with which the study is to be audited.d)Verify that the protocol is assigned to a weekly safety monitoring conference.e)Assess the prioritization of proposed trials in the context of patient and staff resources.f)Affirm relevance of the proposed clinical trial to the mission of the UCCCC.g)Score protocols for subsidy awards.h)Terminate/close a research project.2.3 – ScopeStudies cannot be activated without CTRC approval, a pre-requisite for IRB approval. As a generalpolicy, protocols undergo full review as outlined below. Protocols that have undergone prior peerreview (e.g. NIH, NCI, FDA, ACS, Cooperative Group) will be eligible for expedited CTRC review,which involves review by the Committee Chair or Vice-Chair who has the option of bringing them tothe full committee if there are specific concerns (e.g. regarding merit, design, and prioritization). TheCTRC has the authority to develop policies and procedures regarding initial review and approval ofcancer clinical trials.a)Standard Protocols (not previously peer-reviewed)The UCCCC Clinical Trials Review Committee will conduct a full Committee review of allcancer-related clinical protocols that have not otherwise undergone external peer review.Multi-institutional protocols supported by the pharmaceutical industry and single institution(investigator IND) industry-supported protocols are also subject to review.b) Clinical ProtocolsProtocols whose primary objective is to develop a novel technology, procedure, or clinicaltool, and that enroll a broad spectrum of patients, only some of whom carry a cancerdiagnosis, will not require CTRC review. On the other hand, protocols whose primaryobjective is to test the validity or limitations of a cancer diagnostic procedure or that enroll acohort of patients with a defined cancer or cancer-prone syndrome will be subject to CTRCreview.c) Consortium ProtocolsProtocols submitted through a consortium can be expedited providing that the following twocriteria are met: 1) The consortium review process must be approved by the Clinical ResearchAdvisory Committee (CRAC) as meeting the standards for robust peer review and 2) thereview by the consortium must be protocol specific. All protocols submitted by a researchconsortium that do not meet the above criteria will receive full Committee review.d) Exempt Protocols4 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

Studies given an exempt status by the IRB will also be exempt by the CTRC and will not bereviewed.e) Externally Peer-Reviewed ProtocolsProtocols that have been externally peer reviewed, such as Cooperative Group protocols orstudies conducted in the context of an NIH grant or contract (i.e. Phase II contract), willundergo expedited review only.f) Compassionate Use and Expanded Access ProtocolsCompassionate use protocols will not require a full Committee review. They will receiveexpedited review.Expanded access studies in which the study drug has shown good activity but has not yet beenapproved by the FDA will be reviewed by the Committee using slightly different criteria.These studies permit use of an effective drug that may be beneficial to subjects and mayprovide additional information on long term use. At the discretion of the CTRC, such studiescould receive special approval on the basis of “compassionate use”.g) Clinical Databases and BanksHIPAA and Human Investigation Regulations require that collection of any humanspecimens or clinical data must be conducted under an IRB approved protocol. In order tomaintain a consistent policy, any such protocols that are specific for cancer patients willrequire CTRC approval. However, because the only objective of these protocols is to collectdata, they will not require full Committee review but will receive expedited review. Anyhypothesis-directed research that utilizes the resources in such a database or bank will thenrequire a follow-up formal clinical protocol, a full CTRC review, and presumably IRBapproval. An investigator can request expedited CTRC review of a protocol, but finaldetermination as to whether a protocol represents a “data and specimen collection device” or aclinical trial requiring full scientific review rests with the CTRC.Protocols in which the only objectives are to evaluate/study previously collected tissue instandard clinical archives or established tissue banks do not require CTRC review if theyundergo review by the Pathology Biospecimen Utilization Committee. Cancer- focused tissueprotocols not reviewed by this committee or protocols requiring prospective tissue collectionand/or prospective clinical data collection will require full CTRC review.h) Annual ReviewsAnnual reviews will be conducted by the Scientific Accrual Monitoring (SAM) Committee toensure compliance with the initially approved data and safety monitoring plan (for more detailplease see SAM Guidelines) and accrual goals.2.4 - StructureProfile of members:Membership includes the Chair, Vice-Chair, the PRMS Coordinator and committee members fromvarious departments within the Division of Biological Sciences including faculty and nurses engaged incancer research. Currently, the Committee has representation from Medical Oncology, Surgery,Pediatrics, Pathology, Radiation and Cellular Oncology, Radiology, and Nursing, as well as5 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

representation from the Biostatistics Core Facility, the Human Imaging Research Office (HIRO), andthe Cancer Clinical Trials Office (CCTO).Appointment:Members are appointed by the Associate Director for Clinical Sciences with approval of the UCCCCDirector. Although appointments are for a three-year term, there is some degree of flexibility to ensurebroad representation from all cancer-related specialties and departments. Members are selected basedon an interest in and experience with cancer clinical research.3.0 - Protocol Submission Process3.1 - OverviewWith the exception of the Department of Pediatrics, and a small minority of protocols managed by theClinical Research Support Office (CRSO), the CCTO currently manages the CTRC submission ofcancer-related protocols for all departments, including Medicine, Surgery, Obstetrics and Gynecology,Radiation and Cellular Oncology, and Radiology. In general, Principal Investigators (PIs) submit theirprotocols to the Cancer Clinical Trials Office (CCTO) and they are given to the appropriate RegulatoryManager. The required documentation is compiled (see below) and the protocols are then submitted tothe CTRC. Once the protocol receives full CTRC approval, the protocol is eligible for review andapproval by the Institutional Review Board (IRB).3.2 – Prospective Study SubmissionTo conduct a prospective study, the Principal Investigator must submit the following (see Appendix 1for details of submission process):a)A written protocol that includes background information and references to support the study,clear objectives, specific research questions, research methods, a definition of study endpointsand statistical considerations, a data and safety monitoring plan, and projected patient accrual.If this is a multi-institutional study, the DSM plan must include procedures for managingSAEs/UPs from affiliate/participating institutions.b) A completed Clinical Trial Submission Form.c) Protocol priority tree (a list of all protocols, including the study being submitted, which arecompeting for the patient population under study).d) Investigational Brochure (if applicable).e) Other submission documents (questionnaires, package inserts, assessment forms, etc asapplicable).3.3 - Retrospective Study SubmissionTo conduct a retrospective study the Principal Investigator must be submit the following:a)A written protocol with background information and references to support the study,study objectives, specific research questions to be addressed, and a definition of study6 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

endpoints and statistical considerations. The protocol should list all the data items tobe analyzed, the status of the data (i.e. paper records, on computer), and the totalnumber of patients.b)The completed CTRC Submission Form.3.4 - Pre-Meeting PreparationThe PRMS Coordinator maintains a log of all protocol submissions. This includes the name ofthe Principal Investigator, title of the protocol and dates of the committee review. The CTRCChair assigns at least two reviewers, as well as a biostatistician to review and present theprotocol at the meeting. Review from additional committee members with special areas ofexpertise such as pathology or pharmacology may also be requested. The PRMS Coordinatorposts the protocols to the password protected web-based electronic protocol review applicationand notifies members that they have protocols to review. .4.0 - Clinical Trials Review Committee Meetings4.1 - Meeting PoliciesMeetings are conducted by the Committee Chair, or in his/her absence, the Vice-Chair. In theabsence of the Chair or Vice-Chair, the Chair appoints a member of the committee to conduct themeeting. At least eight committee members must to be present to achieve a quorum. Meetingsare held monthly and minutes are recorded by the PRMS Coordinator and saved in electronicfiles.The CTRC review process is consider an “open” review and reviewers are encouraged to directlycontact Principal Investigators for clarification at any time during the review process. A PrincipalInvestigator is welcome to attend the CTRC meetings to hear his/her protocol discussed, and toaddress comments that are raised by the Committee. If a reviewer is unable to attend the meeting,he/she may provide a written review to the Chair or Vice-Chair for presentation at the meeting.The Chair, with the assistance of the Vice-Chair and the PRMS Coordinator, are responsible forcorrespondence to the Principal Investigator regarding necessary revisions, approval or deferralof the study. Copies of the outcomes letters are sent to the Principal Investigator and theRegulatory Affairs Manager. When the study is approved by the CTRC, the PRMS Coordinatoruploads the approval or approval with revisions letter into AURA IRB, the electronicadministrative system used by the University of Chicago IRB.For protocols that receive an “approval with revision”, the Principal Investigator must respond tothe CTRC review within 60 days. The PRMS Coordinator mails one reminder prior to thedeadline date. If the Principal Investigator fails to respond, the protocol is deferred and will needto be resubmitted and reviewed at a full Committee meeting.7 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

Upon receipt of revisions, the CTRC Chair or Vice-Chair can grant full approval to protocolsinitially receiving an “approved with revisions”. The full committee must discuss revisedprotocols that were deferred.A new protocol that appears to be a resubmission of a previous disapproved protocol must beaccompanied by the previous protocol and a detailed letter indicating how the new protocoldiffers. If the PI wishes to appeal the decision, the PI must present a detailed justification letterto the CRAC committee for consideration.4.2 - Meeting OutcomesAfter a full presentation and discussion of a protocol by the reviewers, the Committee arrives at aconsensus and protocols receive either:a) Approval: Protocol requires no changes (no action required).b) Approval with Revisions: Protocol has minor issues needing clarification. Studies thatreceive an “Approval with Revisions” for which no response is received from thePrincipal Investigator within 60 days are deferred.c) Deferral: Protocol has major issues. This could include major concerns with studydesign, scientific rationale, or adequacy of biostatistical input. Protocol must be rereviewed at a full CTRC meeting before approval will be granted.d) Disapproval: Protocol disapproved due to poor scientific merit and/or as the studydesign is unlikely to meet the study objectives. If a PI wishes to appeal the CTRCdecision, the PI can appeal the decision to the Clinical Research Advisory Committee(CRAC).4.3 - Subsidy ScoringBased on the implementation by the Cancer Center of a Chargeback System for CCTO services,a new scoring system has been added to the CTRC review for institutional trials. Scoring isbased on the study’s scientific merit and scientific priority. The descriptor score (1. outstanding;2. good solid study design; 3. adequate; 4. deferred; 5. disapproved) determines the study’seligibility for a UCCCC subsidy to cover regulatory management fees. Studies receiving a scoreof one or two are eligible to receive a subsidy, with specific fund allocations made by theClinical Research Advisory Committee (CRAC).4.4 – Amended Protocol ReviewIn the event a protocol previously reviewed and approved by the CTRC has been modifiedsignificantly to change the scope of the trial (e.g. doubled sample size, addition of treatment arm,etc), the protocol can be resubmitted to the CTRC for full committee re-review. This re-reviewoption will be based on the Principle Investigator’s or IRB’s discretion.8 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

5.0 – Scientific and Accrual Monitoring Committee5.1 - IntroductionThe second PRMS Committee, the Scientific and Accrual Monitoring Committee (SAM), isresponsible for the ongoing annual review of study progress. The Committee is appointed by theChair and approved by the UCCCC Director.5.2 - PurposeThe purpose of the Scientific and Accrual Monitoring Committee is to monitor the progress ofCTRC-approved studies in terms of both accrual and scientific priority. Specifically SAMreviews trials to:a) Ensure that the conduct of the study is in compliance with the approved Data SafetyMonitoring plan.b) Evaluate compliance with any stipulations placed on the research at the time of CTRCinitial review.c) Review study progress, specifically accrual to date compared to projected accrual, todetermine if the trial should be continued based upon the likelihood of timely completionin meeting its scientific goals.d) Review the rate of accrual to ensure the study has not exceeded the targeted accrual asstated in the protocol. Review accrual of women and minorities relative to the proportionof these sub-groups in the disease specific population. If a multi-center study is reviewed,only institutional accrual rate will be taken into account.e) The SAM is authorized to change the risk level initially assigned by the CTRC on thebasis of accumulating data and number of Unanticipated Problems.5.3 - ScopeThe SAM committee has the authority to develop policies and procedures regarding annualreview of cancer clinical trials. Studies recommended for study closure by SAM are brought tothe CRAC for further discussion. After CRAC review, the study is brought to the CTRC for finaldetermination on closure. On studies for which the Associate Director for Clinical Sciences isparticipating, or otherwise has a conflict of interest, SAM recommendations are submitted to theUCCCC Director, who works with the CRAC to review the study and then forwards therecommendation to the CTRC to determine study closure.9 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

5.4 - StructureProfile of members:The SAM Committee includes diverse representation from various departments in the Divisionof Biological Sciences comprised of individuals with representation from Pediatrics, Surgery,Medicine, Section of Hematology Oncology, Health Studies, Neurology, Obstetrics/Gynecology,and Nursing who engage in cancer clinical research.Appointment:. Members will serve for a term of 3 years, although membership duration will be flexible tomaintain the required depth and breadth of expertise related to the spectrum of clinical researchconducted at the UCCCC.6.0 – Scientific and Accrual Monitoring CommitteeProcedures and Meetings6.1 - Pre-Review Processa) All open protocols are reviewed annually, generally near the time of IRB continuingreview.b) The PRMS Coordinator generates a protocol and accrual summary (including studystatus and DSM plan) from the centralized database (Velos) for each protocol beingreviewed.c) PRMS Coordinator assigns studies to specific Committee members for review.d) The PRMS Coordinator uploads electronic copies of the annual renewal material(protocol, consent, IRB continuing renewal form, Velos summary of accrual, and anystudy progress reports).e) PRMS Coordinator emails members informing them of their assignments.6.2- Review Processa) SAM members are given materials at least one week prior to the meeting and they areresponsible for completing an online Reviewer Worksheet for each assigned study.b) Reviews and recommendations are then presented to the committee and discussed at themonthly meetings.10 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

6.3 - Review Outcome, Notification and Study Closurea) Each study reviewed receives one of the following designations:- Approval: the study can continue without change.- Conditional approval/decision pending: the committee requests clarification or moreinformation in order to formulate a recommendation.- Recommendation of Closure.b) The PRMS Coordinator distributes an automatic email generated during the meeting tothe study PIs, outlining the committee’s recommendations, including requests foradditional information.c) If the study PI receives a conditional approval/decision pending, the PI is required tocomplete the SAM PI Response Form/Corrective Action Plan (Appendix 2).d) If the PI has not responded within two weeks, a reminder email is issued by the PRMSCoordinator.e) All responses are reviewed by the SAM Chair and members of the Committee at the nextSAM Committee meeting to determine the final outcome.f) In instances where closure has been recommended by the Committee and the investigatordeclines to follow the recommendation, the matter is referred to the CRAC committee fordiscussion. After CRAC review, the study is brought to the CTRC for finaldetermination on closure.6.4 - Review of AmendmentsThe committee approves all protocol amendments which are reviewed at the time of the annualreview.6.5 – Studies Exempt from ReviewNon-therapeutic trials, such as retrospective chart reviews, tissue-banking trials, and umbrellagrants, are exempt from SAM review.6.6 - Meeting PoliciesMeetings are conducted by the Committee Chair, or in his/her absence, the Vice-Chair. Aquorum must include the Chair or Vice Chair and at least 2 committee members. The PRMSCoordinator assists the Chair and/or the Vice-Chair in the development of meeting agendas,policies and procedures, assures that minutes are written and maintained, and coordinatesdistribution of protocols to committee members and distribution of committee recommendationsto the Principal Investigators of the studies. Meetings are held monthly and minutes are recordedby the PRMS Coordinator and placed in the electronic SAM folder in the T-Drive.11 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

6.7 - Subsidy ScoringBased on the implementation by the Cancer Center of a Chargeback System for CCTO services,a new scoring system has been added to the SAM review for institutional trials. Scoring is basedon the study’s scientific merit and scientific priority. The descriptor score (1. excellent; 2.adequate; 3. poor) determines the study’s eligibility for a UCCCC subsidy to cover regulatorymanagement fees. Studies receiving a score of one or two are eligible to receive a subsidy, withspecific fund allocations made by the Clinical Research Advisory Committee (CRAC).12 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

Appendix 1New Submission to the CTRC1) Must meet the deadline date of 12 noon the Monday a week and a half before themeeting. For example, for a CTRC Meeting held on Thursday, March 1, 2012, theprotocol submission deadline would be Monday, February 20, 2012. If a holiday falls onthe Monday, the submission would be due the Tuesday after the holiday.2) Must provide one electronic copy of:A) The protocol (see appendix 2 for a template for Non-Therapeutic Trials)B) The Clinical Trials Submission Form (Can be obtained from Velos or below inSub-Section A)C) Priority Tree [This is a list of all studies (including the study being submitted) whichare competing for the same patient population; if applicable].D) Investigational Brochure (If applicable)E) Other Submission Documents (Questionnaires, Package Insert, Assessment forms,etc)PLEASE NOTE: ALL submitted items MUST be emailed to the PRMS Coordinator. Theemail MUST be titled NEW CTRC SUBMISSIONMeeting1) CTRC Meetings are generally held the first Thursday of each month, unless rescheduledby the CTRC Chair.2) Acknowledgment letters will be emailed one week after the meeting at the end of thebusiness day. If distribution of the letters is expected to be greater than one week, anemail will be sent by the PRMS Coordinator of the expected delivery date.Response based on Outcomes of the CTRC Meeting1) Approved – No response is needed2) Approved with Revisions – A response is required from the PI. The letter must addressall the committee’s queries. The letter should be addressed to the attention of the Chairand Vice-Chair. The letter must address each query point by point. All changes to anysubmitted document must be highlighted. ONE electronic (emailed) copy of all updatedmaterials must be submitted with the response. The changed sections should behighlighted. Do not provide copies of documents which have not been altered.3) Deferred - A response is required from the PI. The letter addressing all the committee’squeries must be submitted. The letter should be addressed to the attention of the Chairand Vice-Chair. The letter must address each query point by point. All changes to anysubmitted document must be highlighted. One electronic (emailed) copy of the protocol,13 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

priority tree and clinical trial submission form must be submitted. If any of the abovedocuments have been updated, submit those copies with the changed section highlighted.The study MUST go back for a full committee review and must be submitted in timeto meet the CTRC meeting submission deadline. The PRMS Coordinator will notifythe IRB, Program Leaders and Contract Specialists of the protocol deferral by the CTRC.4) Disapproval – The trial cannot be activated at the U of C. If the PI of the study chooses toseek further approval, an appeal can be submitted to the Clinical Research AdvisoryCommittee (CRAC).Expedited Studies1) A study can be expedited if it is one of the following:A)B)C)D)E)F)G)H)Compassionate Use StudyCo-Operative Group Study (i.e. CALGB, SWOG, GOG, COG, etc)NCI Funded Study – Grant Information should be providedTissue Banking StudyDatabase Collection StudyRetrospective Chart ReviewGrantOtherwise peer-reviewed (e.g. NIH grant or consortium trials)If the submitted study meets one of the above definitions, one copy of the following documentsis needed:A) The protocolB) The Clinical Trials Submission Form can be obtained from Velos or see Sub-SectionA.C) Priority Tree: This is a list of all studies competing for the same patient populationwhich should include the study being submitted for review.D) Investigational Brochure (if applicable).PLEASE NOTE: ALL submitted items MUST be emailed to the PRMS Coordinator. Theemail MUST be titled NEW CTRC SUBMISSIONExpedited studies DO NOT need to meet the CTRC meeting deadline. The study can besubmitted at any time. Although there is NO set turnaround time for distribution of approvalletters, delivery usually takes 7 days to allow time for review by the Chair or Vice-Chair.14 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

Sub-Section AClinical Trial Submission FormA. STUDY SUMMARYPrincipal Investigator:IRB#:Study Title:1.) Is this an investigator-initiated study? Investigator-initiated studies are those for which you generated theidea and had majority input into design and writing of the protocol.YesNo2.) Division (check one):CRC AnesthesiaCRC GynCRC PedsCRC Health StudiesCRC PsychiatryCRC Hem/OncCRC Rad/OncCRC MedicineCRC RadiologyCRC Pathology3.) Disease Site(s):4.) National Accrual Goal (If applicable):5.) Local (U of C) Sample Size:6.) How long (months/years) will it take to complete accrual?:7.) Phase:N/APilot/FeasibilityPhase IPhase I/IIPhase IIPhase II/IIIPhase IIIPhase III/IVPhase IVPhase IV/VPhase V8.) Sponsor(s):9.) Is this an Investigator IND/IDE study?If so, what is the IND/IDE number?10.) Research Type (Sponsor Type):National Cooperative Group Trials15 University of Chicago Comprehensive Cancer Center PRMS Guidelines and Proceduresv. 6/2/2019

Other Externally Peer-Reviewed Trials: R01s and P01s or other trial mechanisms fundedby NIH or supported by other peer-reviewed funding organizations, including the following:a. Agency for Healthcare Research and Quality (AHRQ)b. American Cancer Society (ACS): national office onlyc. American Foundation for AIDS Research (AFAR)d. American Institute for Cancer Research (AICR)e. Cancer Research Foundation of Americaf. Center for Disease Control (CDC)g. Central Office of the Veterans Administration (VA) – excluding local/regional awards and“block” grantsh. Environmental Protection Agency (EPA)i. Food and Drug Administration (FDA)j. Howard Hughes Foundationk. Leukemia and Lymphoma Society 2l. Multiple Myeloma Research Foundationm. National Institute for Occupational Safety and Health (NIOSH)n. National Science Foundation (NSF)o. Susan G. Komen Breast Cancer Foundationp. University of California-Wide Breast Cancer Research Programq. U.S. Army (DOD) special research programs in ovarian, breast and prostate cancerInstitutional Trials: In-house, internally reviewed trials, including those collaborativestudies conducted with industry sponsorship in which the center is a primary contributor tothe design, implementation, and monitoring of the trial, or participation in a multi-site trialinitiated by an investigator at another center.Industrial Trials: Design and implementation of the study is controlled by the pharmaceuticalcompany11.) Study Scope:Single-CenterMulti-Centera.If Multi-center study, total # of sites participating?b.Is U of C the lead institution? (If so, please list participating sit

Chair assigns at least two reviewers, as well as a biostatistician to review and present the protocol at the meeting. Review from additional committee members with special areas of expertise such as pathology or

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